Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar (Germectomy)

January 15, 2025 updated by: Amerigo Giudice

Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar: Assessment of Post-operative Sequelae

The main objective of the study is to compare the effects of the piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective of the study is to compare the effects of piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars. Post-operative swelling is analyzed using a photogrammetry facial scanner (Marathon MT-4000).

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Amerigo Giudice, Prof, MD, PhD
  • Phone Number: 09613647215
  • Email: a.giudice@unicz.it

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Recruiting
        • Magna Graecia University of Catanzaro
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged between 14 and 24 years, with both lower third molars in the developmental stage (with incompletely formed roots) and requiring extraction of both for prophylactic, therapeutic or strategic reasons
  • Good quality of radiographic investigations (CBCT)
  • Good health status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group: Piezoelectric Surgery
Use of piezoelectric technique in third molar germectomy procedures
Procedure: Piezoelectric technique in third molar germectomy
Application of piezoelectric technique in third molar germectomy procedures
Active Comparator: Control group: Traditional Surgery
Use of traditional technique in third molar germectomy procedures
Procedure: Traditional technique in third molar germectomy
Application of traditional technique in third molar germectomy procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial swelling qualitative analysis
Time Frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To compare the effectiveness of piezosurgery in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes)
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Facial swelling quantitative analysis - volumetric differences
Time Frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To compare the effectiveness of piezosurgery in reducing facial swelling using quantitative three-dimensional analysis ( volumes measured in cm3)
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Facial swelling quantitative analysis - linear differences
Time Frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To compare the effectiveness of piezosurgery in reducing facial swelling using quantitative three-dimensional analysis (linear differences measured in cm2)
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trismus analysis
Time Frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To assess the effects of piezosurgery on trismus (measured in cm)
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Pain analysis with Visual analogue scale (VAS)
Time Frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To assess the effects of piezosurgery on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome.
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amerigo Giudice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 372/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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